In May 2007, Carrie and Shawn Pratt agreed to sign up their severely premature daughter, Dagen, for a government-funded study being conducted at Duke University Hospital. The Pratts say they were told that researchers simply were gathering information to help other children.

“We never understood the study to be based on manipulating her oxygen level to meet [researchers’] needs,” Carrie Pratt says.

They already had lost a preemie son four years before Dagen was born. They say they can’t understand why medical professionals would have suggested enrolling their frail, newborn daughter in an experiment that could put her at further risk.

“When you have a small child, a micro-preemie, on a ventilator with see-through skin and fighting for her life … it is the most humbling, sad experience of your life,” Carrie Pratt says in an interview. “So, of course we would agree to participate in a study if it meant collecting info or data to help someone else. But certainly not at the expense of our daughter.”

Today, the Pratts wonder whether the study, called SUPPORT, contributed to Dagen’s health issues. She suffered multiple incidences of collapsed lungs, breathing problems, and other life-threatening conditions. Diagnosed with retinopathy, Dagen had to have laser eye surgery when she was 2 months old. She has cerebral palsy. Now 7, she often wears orthotics on both legs.

The consent form signed by parents did not disclose one controversial aspect of the experiment: The preemies’ oxygen monitors intentionally were altered to provide false readings so that medical staff wouldn’t be tempted to adjust the babies’ oxygen out of their study-assigned range.

More babies who received higher levels of oxygen ended up with serious vision disorders. The low-oxygen preemies were more likely to die. The results, published in the New England Journal of Medicine in May 2010, sparked ongoing ethical questions and complaints.

Little over nine months ago, hundreds of researchers and academics from around the globe gathered in person or via teleconference to address the supposed confusion surrounding informed consent in the wake of the SUPPORT controversy.

“We were guaranteed that the study wouldn’t hurt Dagen in any way, that it was just gathering information,” Shawn Pratt told the audience academics and research scientists, “and were shocked to learn the care she received was based not on what she needed, but on some protocol.”

Dagen’s father continued: “We want to know, as information comes in, why the risks and intent of the study were not clear. If it were clear, we wouldn’t have taken part in the study.”

‘That Wasn’t Clear?’

At least one of three HHS panelists who moderated the meeting appeared dumbfounded by the Pratts’ personal story after lofty discussions about the greater good.

The HHS ethics office director, Dr. Jerry Menikoff, was on the panel, but he wasn’t the one who spoke up.

Rather, it was Dr. Robert Temple, deputy director for clinical science at the Food and Drug Administration’s Center for Drug Evaluation and Research.

“Just to be sure I understood: You got some kind of consent form, but I take it you’re saying that you couldn’t tell from that, that there were actually two things that she was going to be randomized to?” Temple asked the Pratts. “But that wasn’t clear? Is that what you’re saying?”

“They said they are collecting data, that don’t worry, she is going to be cared for,” Carrie Pratt answered.

“So they didn’t really communicate that it was in fact an experiment?” Temple asked.

Sharrissa Cook also spoke about her son, Dreshan, at the HHS meeting. Cook was just 25 weeks into her pregnancy when she gave birth to a critically ill baby boy in October 2006. She is now part of a lawsuit alleging that the University of Alabama at Birmingham Hospital, the lead study site, misled her and other SUPPORT parents.

Dreshan, who weighed a fragile 1 pound, 11 ounces at birth, faces a myriad of health problems at age 7.

“Had I known the full extent of the study, I would not have given my consent. … I unknowingly placed my son in harm’s way,” Cook said. “I trusted them with my baby’s life … My son is a live, breathing human being. He is not simply a subject.”

HHS has yet to issue conclusions about what occurred during the multiyear experiment on preemies.

As Cook, the Pratts and other parents demand answers, a source who conducts clinical trials—but wasn’t involved in SUPPORT—provides insight into research dynamics.

Scientists and other researchers face “such incredible pressure today to advance research and their own position and standing in the research community,” the source says. As a result, “a lot of rationalization can take place” on the question of what to tell human test subjects.

Or in this case, what to tell their anxious and vulnerable parents.

Some researchers appear to be turning criticism of SUPPORT on its head. They argue that informed consent should be suspended altogether in such studies, which they contend merely evaluated an already-approved, widely used “standard of care” treatment.

“[But] seriously, can anyone blame them?” she asks. “One thing is for sure, anyone approaching us to participate in a study can just keep walking.”

Dr. Michael Carome, a former leader of the HHS ethics office who now directs health research for the consumer watchdog group Public Citizen, says talk of withholding more information from test subjects is dangerous.

Former HHS ethics official Michael Carome, now with Public Citizen, faults HHS for not enforcing standards in the baby oxygen trials. (Photo: Angela Bradbery/Public Citizen)

Carome says he considers it “highly likely” that many, if not most, parents would have refused to enroll their babies in the NIH-financed study had they been “appropriately informed about the nature of the research and its risks.”

But the answer, Carome argues, isn’t to hide the risks.

“Some experiments maybe just can’t be done,” he says.

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Sharyl Attkisson, an Emmy award-winning investigative journalist, is a former senior independent contributor to The Daily Signal. She hosts the Sunday morning news program "Full Measure" and is the The New York Times best-selling author of "The Smear: How Shady Political Operatives and Fake News Control What You See, What You Think, and How You Vote" and "Stonewalled." Send an email to Sharyl.

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